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Found 9681 cases where Vaccine is PNC13

Case Details (Reverse Sorted by Appearance Date)

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VAERS ID:521002 (history)  Vaccinated:2013-12-27
Age:0.2  Onset:2013-12-27, Days after vaccination: 0
Gender:Female  Submitted:2014-01-04, Days after onset: 8
Location:Tennessee  Entered:2014-01-28, Days after submission: 24
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data:
CDC 'Split Type': TN13011
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSL24JG0IMLL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.J0070960IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG750640IMRL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB374A0PO 
Administered by: Public     Purchased by: Public
Symptoms: Crying, Injection site induration, Injection site movement impairment, Injection site swelling, Pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (broad)
Write-up: (L) upper thigh swollen - hard area at inj. site. Infant cries when (L) leg extended and limits her own movement of the limb.

VAERS ID:521044 (history)  Vaccinated:2014-01-20
Age:0.4  Onset:0000-00-00
Gender:Male  Submitted:2014-01-23
Location:Michigan  Entered:2014-01-28, Days after submission: 5
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: NKDA; NK Birth defects; Undescended (R) testicle
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (INFANRIX)GLAXOSMITHKLINE BIOLOGICALSAC14B182BO1IMLL
HEPA: HEP A (VAQTA)MERCK & CO. INC.J0030800IMRL
HIBV: HIB (PEDVAXHIB)MERCK & CO. INC.H0205961IMLL
IPV: POLIO VIRUS, INACT. (IPOL)SANOFI PASTEURH13051SCRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF188761IMLL
Administered by: Private     Purchased by: Private
Symptoms: Drug administered to patient of inappropriate age, No adverse event
SMQs:
Write-up: No adverse events associated with Hep A given at 4 months age.

VAERS ID:521053 (history)  Vaccinated:2014-01-28
Age:0.2  Onset:2014-01-28, Days after vaccination: 0
Gender:Female  Submitted:2014-01-28, Days after onset: 0
Location:California  Entered:2014-01-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None. Patient improved with ice/Tylenol but left office with less swelling of her thigh.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSFF7230IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH876AB0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH336040IMRL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J008363 PO 
Administered by: Unknown     Purchased by: Private
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: 7 x 5 cm red, tender, indurated right thigh and extremely fussy. After applying ice and administering Tylenol, induration 4x 4 cm and less fussy.

VAERS ID:521007 (history)  Vaccinated:2013-05-31
Age:0.4  Onset:2013-06-02, Days after vaccination: 2
Gender:Male  Submitted:2014-01-27, Days after onset: 239
Location:Foreign  Entered:2014-01-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data:
CDC 'Split Type': 2014019650
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS 1IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH 1IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Decreased appetite, Growth retardation, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)
Write-up: This is a spontaneous report from a contactable physician, received from the foreign regulatory authority. Regulatory authority report number 233618. A 4-month-old male patient received on 31May2013 for the second dose of PREVENAR 13 (lot number G19209, expiration date unknown), intramuscular at single dose and the second dose of INFANRIX HEXA (lot number A21CB606A, expiration date unknown), at an unspecified dose. Previously on 19Apr2013 patient received the first dose of PREVENAR 13 (lot number F47920, expiration date unknown), intramuscular at single dose and on 05Apr2013 the first dose of INFANRIX HEXA, lot number A21CB380A, expiration date unknown), intramuscular at an unspecified dose. The patient medical history was not reported. Concomitantly patient received milk powder for newborn babies (APTAMIL). The patient experienced decreased appetite on 02Jun2013 considered as medically significant by the reporter who described the event as severe inappetence, episodes of vomiting and growth arrest. No action was taken as consequence of the event. The patient was not recovered yet at reporting time.

VAERS ID:521009 (history)  Vaccinated:0000-00-00
Age:82.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-01-27
Location:Foreign  Entered:2014-01-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 2014020806
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Rhinorrhoea, Soft tissue inflammation, Vomiting
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This is a spontaneous report from a contactable pharmacist through the medical information team. This is the second report out of two reports from the same pharmacist, reporting the same events to different patients. A 82-years-old patient of an unspecified gender received PREVENAR 13, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. After vaccination (unspecified date), the patient experienced soft tissue inflammation lower than the injection site, injection site cellulitis, injection site redness, injection site pain, injection site oedema, vomiting and rhinorrhea. In order to treat the events the patient receive antibiotic treatment and for oedema the pharmacist suggested the use of compresses. At the time of reporting, the outcome of the events was unknown.

VAERS ID:521010 (history)  Vaccinated:2014-01-14
Age:62.0  Onset:2014-01-15, Days after vaccination: 1
Gender:Female  Submitted:2014-01-27, Days after onset: 12
Location:Foreign  Entered:2014-01-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 2014020290
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Cellulitis, Local swelling, Pain, Pyrexia
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 62-year-old female patient received a dose of PREVENAR 13 (Lot. G96206 05/2012, Expiration date: Apr2015) 0.5 ml single dose intramuscularly on 14Jan2014. Relevant history, concomitant medications, laboratory data and past drug history were none. On 15Jan2014, the patient experienced swelling of arm, cellulitis, pain and fever. All events were assessed as important medical events. The patient was treated with intravenous TAXIM 500mg thrice a day on 19Jan2014. Clinical outcome of the events was unknown at time of this report. The physician believed that the adverse event may be due to injection infected needle or due to defective manufacturing.

VAERS ID:521017 (history)  Vaccinated:0000-00-00
Age:67.0  Onset:0000-00-00
Gender:Unknown  Submitted:2014-01-27
Location:Foreign  Entered:2014-01-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 2014018077
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  SYRUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Rhinorrhoea, Soft tissue inflammation, Vomiting
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: This is a spontaneous report from a contactable pharmacist through the medical information team. This is the first report out of two reports from the same pharmacist, reporting the same events to different patients. A 67-year-old patient of an unspecified ethnicity and gender received PREVENAR 13, via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. After vaccination (unspecified date), the patient experienced soft tissue inflammation lower than the injection site, injection site cellulitis, injection site redness, injection site pain, injection site oedema, vomiting and rhinorrhea. In order to treat the events the patient receive antibiotic treatment and for oedema the pharmacist suggested the use of compresses. At the time of reporting, the outcome of the events was unknown.

VAERS ID:521022 (history)  Vaccinated:2014-01-06
Age:0.3  Onset:2014-01-10, Days after vaccination: 4
Gender:Male  Submitted:2014-01-27, Days after onset: 17
Location:Foreign  Entered:2014-01-28, Days after submission: 1
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown; The patient birth weight was 3106 g. The patient had no family history and body temperature before the vaccination was 36.8 degrees Centigrade.
Diagnostic Lab Data: Body temperature, UNK, 36.8 Degree C
CDC 'Split Type': 2014SA009860
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (ACTHIB)SANOFI PASTEURJ15121SCUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH13C03A1UNUN
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.H0187760UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Abdominal distension, Enema administration, Haematochezia, Intussusception, Irritability, Mucous stools, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Ischaemic colitis (broad)
Write-up: Initial report received from the health authority via a pediatrician on 23 January 2014. Health Authority reference number: V13001120. A 3-month-old male patient had received 2nd dose of 0.5 ml of ACT HIB (lot number: J1512 and site of administration was not reported) Subcutaneously, received an initial dose of ROTATEQ (manufacturer other, lot number: H018776, dose in series, route and site of administration was not reported) and had received 2nd dose of PREVENAR 13 (manufacturer other, lot number: 13C03A, route and site of administration was not reported) on 06 January 2014. The patient birth weight was 3106 g. The patient had no family history and body temperature before the vaccination was 36.8 degrees Centigrade. On 10 January 2014, at 05:00 am, he was fretful, at 07:00, he experienced repetitive vomiting and at 15:00 he was taken to another clinic and referred to the pediatric department of another hospital. He was admitted to the hospital and received infusion. On 11 January 2014, vomiting persisted and invagination of intestine was suspected, but it could not be diagnosed based on examinations. On 12 January 2014, he had no vomiting, was fretful and developed bloating. Mucous and bloody stools were observed while an enema was administered. Invagination of intestine was diagnosed based on examinations. He did not respond to medical therapy and was transferred to the pediatric department of the reporting hospital. On 13 January 2014, he was admitted to the department of pediatric surgery of the reporting hospital for invagination of intestine. On 20 January 2014, he recovered from the invagination of intestine and was discharged from the hospital. Invagination of intestine: Reporting pediatrician''s seriousness assessment: Serious (inpatient/prolonged hospitalization). Reporting pediatrician''s causality assessment: Unknown. Reporting pediatrician''s comment: There was no alternative explanation for the event.

VAERS ID:521103 (history)  Vaccinated:2014-01-14
Age:0.2  Onset:2014-01-17, Days after vaccination: 3
Gender:Male  Submitted:2014-01-28, Days after onset: 11
Location:Foreign  Entered:2014-01-28
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Unknown
Preexisting Conditions:
Diagnostic Lab Data: UNK
CDC 'Split Type': B0963136A
Vaccination
Manufacturer
Lot
Dose
Route
Site
HIBV: HIB (NO BRAND NAME)UNKNOWN MANUFACTURER  SCUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  SCUN
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSAROLA582AA PO 
Administered by: Other     Purchased by: Other
Symptoms: Asthenia, Haematochezia, Hypotonia, Intussusception, Mood altered, Nasopharyngitis, Surgery, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: On 17 January 2014, 3 days after vaccination with ROTARIX liquid formulation, the subject experienced common cold and was taken to the department of obstetrics and gynecology. On 8 January 2014, the subject was in a bad mood and had vomiting. On 19 January 2014, the subject was limp (weakness), and bloody stool was noted. The subject was hospitalized and invagination of intestine was diagnosed. The subject was treated with surgery. At the time of reporting, the events were unresolved. The physician considered the investigation of intestine was related to vaccination with ROTARIX liquid formulation.

VAERS ID:520852 (history)  Vaccinated:2014-01-20
Age:0.5  Onset:2014-01-21, Days after vaccination: 1
Gender:Male  Submitted:2014-01-23, Days after onset: 2
Location:Utah  Entered:2014-01-27, Days after submission: 4
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data: Urticaria
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAP: DTAP (DAPTACEL)SANOFI PASTEURC4508AA2IMUN
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4779AA0IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUH999AC2IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHH419482IMUN
Administered by: Private     Purchased by: Private
Symptoms: Rash generalised, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow)
Write-up: Urticaria. Rash entire body appeared the next day of vaccination. Treatment: Cetirizine 5 mg/5 mL oral sol. 2.5 mL for 7 days.

VAERS ID:520863 (history)  Vaccinated:2013-12-05
Age:0.6  Onset:2013-12-05, Days after vaccination: 0
Gender:Female  Submitted:2014-01-24, Days after onset: 50
Location:Louisiana  Entered:2014-01-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Diagnostic Lab Data: UA - normal; Urine culture negative
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSJ9M542UNRL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH869AA2UNLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG392912UNLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41CB374A0PO 
Administered by: Private     Purchased by: Public
Symptoms: Body temperature increased, Culture urine negative, Loss of consciousness, Pallor, Urine analysis normal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: Approximately 3 - 4 hrs after vaccine administration, patient was in stroller noted to have pallor, vomiting with loss of consciousness. No jerking or tremors noted. Lasted 1 - 2 min. EMT''s called and taken to ER - noted temp 103. In ER, noted normal UA and negative urine culture. Patient recovered, followed up the next day and was well.

VAERS ID:520871 (history)  Vaccinated:2013-05-23
Age:0.8  Onset:2013-05-24, Days after vaccination: 1
Gender:Male  Submitted:2014-01-27, Days after onset: 248
Location:California  Entered:2014-01-27
Life Threatening? No
Died? No
Permanent Disability? Yes
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: No
Preexisting Conditions: No
Diagnostic Lab Data:
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG689121UNLG
Administered by: Private     Purchased by: Private
Symptoms: Developmental delay, Diet refusal, Hypotonia, Somnolence, Underweight, Weight decreased
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: After vaccine slept all day. Woke up refused to eat. Started eating became extremely picky. Over the next 10 days he became floppy and lost weight. Stopped meeting milestones. Diagnosed with low muscle tone, underweight and developmental delay. As a baby he was strong and healthy.

VAERS ID:520874 (history)  Vaccinated:2014-01-24
Age:0.2  Onset:2014-01-24, Days after vaccination: 0
Gender:Male  Submitted:2014-01-27, Days after onset: 3
Location:Massachusetts  Entered:2014-01-27
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None.
Preexisting Conditions: Patient has a systolic murmur, grade 2/6.
Diagnostic Lab Data: None.
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALS92J920IMLL
HIBV: HIB (ACTHIB)SANOFI PASTEURUH877AA0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG986520IMLL
RV5: ROTAVIRUS (ROTATEQ)MERCK & CO. INC.J0012520IMUN
Administered by: Unknown     Purchased by: Public
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow)
Write-up: Patient became fussy a few minutes after receiving vaccines on 1-24-14. Patient''s mom undressed him around noontime later that day, and she noticed that patient had redness and swelling on both legs, starting at the injection sites on both legs and travelling distally to his toes, the right leg being worse than the left. Area of redness seemed tender to touch. Patient was brought by his mother to ED, where patient was given an oral dose of Benadryl. Pt''s mom reports that 20-25 minutes after the administration of Benadryl to patient, patient''s symptoms resolved. Symptoms have not come back. Patient also had a heart rate of 170-200 bpm while at the ED, heart rate was normal when patient seen at pediatrician on 1-27-14 for recheck appointment.

VAERS ID:520795 (history)  Vaccinated:2013-10-09
Age:0.9  Onset:2013-10-09, Days after vaccination: 0
Gender:Female  Submitted:2014-01-24, Days after onset: 107
Location:Foreign  Entered:2014-01-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Demyelination, probable alterations of myelinations results from magnetic resonance; Hypotonia, axial hypotonia; Motor developmental delay; PREVENAR 13, No adverse event, first dose; PREVENAR 13, No adverse event, Second dose; INFANRIX HEXA, No adverse event, First dose; INFANRIX HEXA, No adverse event, Second dose
Diagnostic Lab Data: Computerised tomogram head, unknown
CDC 'Split Type': 2014019213
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALSA21CB798C2IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG799052IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Computerised tomogram head, Gaze palsy, Hypotonia, Oxygen saturation decreased, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad)
Write-up: This is a spontaneous report from a contactable pediatrician received from the Regulatory Authority. Regulatory authority report number 233304. A 10-month-old female patient received at 10 a.m. of 09Oct2013 the third dose of PREVENAR 13 (lot number G79905, expiration data unknown) and the third dose of INFANRIX HEXA (lot number A21CB798C, expiration date unknown) both intramuscular. Medical history included demyelination from an unknown date, hypotonia from an unknown date and motor development delay from an unknown date. The reporter also specified that no problem had occurred with previous administrations of vaccines; patients grandmother and patients paternal uncle had suffered from febrile convulsions in childhood; the patient was already in assessment for motor retardation with axial hypotonia; then probable alterations of miellnization resulted from magnetic resonance and further investigations were still ongoing. The patient''s concomitant medications were not reported. The patient on 09Oct2013 experienced hypotonia, fever and respiratory arrest. The seriousness of all the events was hospitalization. The events were described as follows: both vaccinations were administered at 10:00 in the morning, and the patient remained apyretic; at 08 p.m. the patient presented a right deviation of head and eyes followed by hypotonia of trunk and limbs, respiratory arrest, desaturation and onset of fever. As consequence of these events the patient was treated with oxygen and a CT brain scan was performed: the results were not provided. The patient completely recovered from the events of 10Oct2013.

VAERS ID:520798 (history)  Vaccinated:2012-10-03
Age:0.2  Onset:2012-10-03, Days after vaccination: 0
Gender:Female  Submitted:2014-01-24, Days after onset: 478
Location:Foreign  Entered:2014-01-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 2014016739
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPIPVHIB: DTAP + IPV + HIB (NO BRAND NAME)SANOFI PASTEUR  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Dyspnoea, Eczema, Hypotonia, Tachycardia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow)
Write-up: This is a spontaneous report received from a consumer via the contactable foreign regulatory agency. The regulatory authority report number is ADR 22385098. An 8 week old female patient of an unspecified ethnicity received PREVENAR 13 at an unknown dosage and PEDIACEL at an unknown dosage, both on 03Oct2012. The patient was reported to have no other medical conditions or concurrent conditions at the time of the vaccinations. The patient''s concomitant medications were not reported. On 03Oct2012, after receiving the vaccinations, the patient experienced becoming floppy, tachycardia and breathlessness. A paramedic was called and he advised that the patient be taken to hospital. The patient was monitored for four hours and then sent home. The patient also developed eczema within days when she had previously had no skin complaints. The action taken in response to the events for PEDIACEL and PREVENAR 13 was not applicable. The patient recovered from the events on an unspecified date. The reporter considered the events as serious as the events were medically important conditions. The regulatory authority considered the events to be serious for an unspecified reason. No follow-up attempts possible. No further information expected.

VAERS ID:520800 (history)  Vaccinated:0000-00-00
Age:1.0  Onset:0000-00-00
Gender:Male  Submitted:2014-01-24
Location:Foreign  Entered:2014-01-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 2014019046
Vaccination
Manufacturer
Lot
Dose
Route
Site
6VAX-F: DTAP+IPV+HEPB+HIB (FOREIGN)GLAXOSMITHKLINE BIOLOGICALS  UNUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETH  UNUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)
Write-up: This is a spontaneous report from a contactable physician received from the foreign regulatory authority. Regulatory authority report number SE-MPA-2014-000319. A 12-month-old male patient of an unspecified ethnicity received PREVENAR 13, and INFANRIX HEXA, both via an unspecified route of administration at an unspecified dose on an unspecified date. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced unconsciousness on 10Jan2014 and was hospitalized. The outcome was recovered with sequelae. The action taken in response to the event was not applicable. No follow-up attempts possible. No further information expected.

VAERS ID:520803 (history)  Vaccinated:2013-10-23
Age:1.4  Onset:2013-10-27, Days after vaccination: 4
Gender:Female  Submitted:2014-01-24, Days after onset: 89
Location:Foreign  Entered:2014-01-27, Days after submission: 3
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Unknown
Diagnostic Lab Data:
CDC 'Split Type': 2014019165
Vaccination
Manufacturer
Lot
Dose
Route
Site
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME)UNKNOWN MANUFACTURERA71CA56PA0IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF989480IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad)
Write-up: This is an initial spontaneous report received from the foreign Regulatory Authority. Regulatory Authority report number 233395. A hospital physician (contactable through Regulatory Authority only) referred that a 17-month-old female patient of an unspecified ethnicity received the 1st dose of PREVENAR 13, lot# F98948, expiration date unknown intramuscular at 0.5 mL and the 1st dose of PRIORIX-TETRA, lot# A71CA56PA, expiration date unknown powder and solvent solution for injection intramuscular at 0.5 mL, both vaccines received on 23Oct2013. No relevant past drugs, relevant concomitant medications and medical history have been provided. On 27Oct2013, the patient experienced acute myocarditis, unspecified. The event was described by reporter as: myocarditis not otherwise specific. The seriousness criterion for this event was hospitalization. Therapeutic measures taken as a result of the event included urgent hospitalization. The outcome of the event was unknown.

VAERS ID:520731 (history)  Vaccinated:2014-01-24
Age:0.6  Onset:2014-01-25, Days after vaccination: 1
Gender:Male  Submitted:2014-01-26, Days after onset: 1
Location:California  Entered:2014-01-26
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: CSF profile - 2WBC, 0RBC, 61 gluc, 16 prot.; UA - clean; Blood/CSF/urine cx - NGTD; Respiratory virus DFA - pending; CRP - 3 (nl <0.5)
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSFF7232IMUN
FLU3: INFLUENZA (SEASONAL) (FLUZONE)SANOFI PASTEURU4711DA0IMUN
HIBV: HIB (ACTHIB)SANOFI PASTEURUH879AA2IMUN
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHG988202IMUN
Administered by: Unknown     Purchased by: Unknown
Symptoms: Blood culture negative, Bradycardia, C-reactive protein normal, CSF culture negative, CSF glucose normal, CSF protein normal, CSF white blood cell count negative, Coma scale, Culture urine negative, Hyporesponsive to stimuli, Hypotension, Hypotonia, Pallor, Pyrexia, Red blood cell count normal, Respiration abnormal, Urine analysis normal, Viral test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad)
Write-up: Decreased muscle tone, poorly responsive, altered breathing (sounded like "hiccups") and pale. Admitted to Hospital where by that time GCS of 15. Had bradycardia, hypotension and altered breathing but all self-resolved by evening. No further fevers.

VAERS ID:520716 (history)  Vaccinated:2012-07-12
Age:1.1  Onset:2014-01-01, Days after vaccination: 538
Gender:Male  Submitted:2014-01-25, Days after onset: 24
Location:D.C.  Entered:2014-01-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: + herpes zoster skin culture
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
HEPA: HEP A (VAQTA)MERCK & CO. INC.0325AE0IMLL
MMR: MEASLES + MUMPS + RUBELLA (MMR II)MERCK & CO. INC.0011AE0IMRL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF451303IMRL
VARCEL: VARICELLA (VARIVAX)MERCK & CO. INC.1792AA0IMLL
Administered by: Unknown     Purchased by: Private
Symptoms: Gait disturbance, Herpes zoster, Injection site pain, Rash, Varicella virus test positive
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow)
Write-up: Developed herpes zoster rash (positive zoster culture) down left leg x lower back. Complaining of pain in left leg with limp.

VAERS ID:520841 (history)  Vaccinated:2013-12-05
Age:0.5  Onset:2013-12-06, Days after vaccination: 1
Gender:Female  Submitted:2014-01-25, Days after onset: 50
Location:Oklahoma  Entered:2014-01-25
Life Threatening? No
Died? No
Permanent Disability? No
Recovered? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Diagnostic Lab Data: None
CDC 'Split Type':
Vaccination
Manufacturer
Lot
Dose
Route
Site
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX)GLAXOSMITHKLINE BIOLOGICALSC4325AA1IMLL
PNC13: PNEUMO (PREVNAR13)PFIZER/WYETHF35421IMLL
RV1: ROTAVIRUS (ROTARIX)GLAXOSMITHKLINE BIOLOGICALSA41FB352A1PO 
Administered by: Private     Purchased by: Private
Symptoms: Crying, Mouth ulceration, Pyrexia
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad)
Write-up: Crying, fever, oral ulcer.

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